The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS in combination with standard of care as a second line treatment in subjects with unresectable and locally recurrent or metastatic colorectal cancer.

To assess the antitumor activity of OCZ103-OS in combination with standard of care in subjects with unresectable and locally recurrent or metastatic colorectal cancer in terms of tumor growth during treatment

To assess the antitumor activity of OCZ103-OS in combination with standard of care in subjects with unresectable and locally recurrent or metastatic colorectal cancer in terms of progression free survival

To assess the peak plasma concentration of OCZ103-OS after administration on day 1 of first cycle.

Amount of OCZ103-OS in serum on day 1 of first cycle.

Number of participants with Adverse Events (AE) as a Measure of Safety and Tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

- To assess the number of adverse events in participants due to IV OCZ103-OS in conjunction with standard chemotherapy (mFOLFOX6- or FOLFIRI-contained regimen) in patients with unresectable and locally recurrent or metastatic colorectal cancer requiring second-line chemotherapy from baseline.

- To assess the effect of OCZ103-OS on overall objective response (OR) in subjects with unresectable and locally recurrent or metastatic colorectal cancer treated concurrently with mFOLFOX6 or FOLFIRI.

This is a single arm, open label study to investigate the safety and efficacy of the use of OCZ103-OS in combination with standard therapy (mFOLFOX6 or FOLFIRI) as a second line treatment in subjects with unresectable and locally recurrent or metastatic colorectal cancer.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically or cytologically proven diagnosis of adenocarcinoma of the colon/rectum with evidence of (1) unresectable and, locally recurrent, or (2) metastatic disease.

Concomitant therapy with other investigational agents or participation in another clinical trial within 30 days prior to enrollment.

Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval > 450 msec for males or > 470 msec for females or uncontrolled intercurrent illness, e.g. unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia < 50 bpm; a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome).

Active uncontrolled bacterial infection.

Concurrent use of drugs that could prolong QT interval (NB: pentamidine is known to induce torsades de pointes) (see Appendix II: List of drugs that could prolong QT interval / we also suggest that you refer to the following link: http://www.azcert.org/medical-pros/drug-lists/bycategory.cfm).

Concurrent use of nephrotoxic drugs (depending on the medical health status of the patient and based on the judgment of the investigator), including but not limited to aminoglycosides, ampho B, foscarnet and cidofovir.

Concurrent use of drugs such as Rifampine and Lamivudine, since these that may be associated with pancreatitis.

Prior malignancy other than colorectal cancer (except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer or localized prostate cancer with undetectable PSA level) unless the prior malignancy was diagnosed and definitively treated at least five (5) years previously with no subsequent evidence of recurrence.

Clinically significant non-malignant lung disease.

History of allergy or hypersensitivity to pentamidine.

Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first dose of study medication.

Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgement of the investigator, excess risk associated with trial participation of study drug administration, or which in the judgement of the investigator, would make the subject inappropriate for entry into this trial.

Use of oral anticoagulants (LMWH is acceptable)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378143